香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何意見，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 TYK Medicines, Inc 浙江同源康醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2410） 自願公告 甲磺酸艾多替尼片（TY-9591片）的新藥上市申請 獲國家藥品監督管理局受理 浙江同源康醫藥股份有限公司（「本公司」，連同其附屬公司統稱「本集團」）自願刊 發，以告知本公司股東及潛在投資者有關本集團最新業務發展的資料。 本公司董事會（「董事會」）欣然宣佈，本公司在研1類新藥甲磺酸艾多替尼片 （TY-9591片）的新藥上市申請（「NDA」）被國家藥品監督管理局（「NMPA」）藥品 審評中心（「CDE」）受理。現將相關情況公告如下： 甲磺酸艾多替尼片（TY-9591片）為奧希替尼的氘代物，生物利用度高，入腦效 果好，本次NDA註冊申報適應症為具有EGFR外顯子19缺失(19DEL)或外顯子 21(L858R)置換突變，並伴有CNS轉移的局部晚期或轉移性NSCLC成人患 ...

消息面上，同源康医药此前公布，公司在研1类新药甲磺酸艾多替尼片(TY-9591片)被国家药品监督管理 局(NMPA)药品审评中心(CDE)纳入优先审评品种名单。 据悉，该药物拟用于治疗具有表皮生长因子受体(EGFR)外显子19缺失或外显子21置换突变，并伴有中 枢神经系统转移的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者的一线治疗。此次被纳入优先评 审，标志着甲磺酸艾多替尼片的审评进程将全面提速，有望更早上市，为中国患者提供新的治疗选择。 智通财经APP获悉，同源康医药-B(02410)午后涨近5%，截至发稿，涨3.65%，报13.06港元，成交额 2890.62万港元。 ...

Core Viewpoint - Tongyuan Kang Pharmaceutical-B (02410) has seen its stock rise nearly 5% in the afternoon trading session, currently up 3.65% at HKD 13.06, with a trading volume of HKD 28.9062 million. The company announced that its investigational first-class new drug, TY-9591 (Axitinib), has been included in the priority review list by the National Medical Products Administration (NMPA) [1][1]. Group 1 - The drug TY-9591 is intended for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 substitution mutations, along with central nervous system metastases [1][1]. - Inclusion in the priority review list signifies an acceleration in the review process for TY-9591, potentially leading to an earlier market launch and providing new treatment options for patients in China [1][1].

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2026年1月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 浙江同源康醫藥股份有限公司 (於中華人民共和國註冊成立的股份有限公司) 呈交日期: 2026年2月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02410 | 說明 | H股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 375,457,818 | RMB | | 1 RMB | | 375,457,818 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 375,457,818 | RMB | | 1 RMB | | 375,457,818 | | 2. 股 ...

据悉，该药物拟用于治疗具有表皮生长因子受体(EGFR)外显子19缺失或外显子21置换突变，并伴有中 枢神经系统转移的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者的一线治疗。此次被纳入优先评 审，标志着甲磺酸艾多替尼片的审评进程将全面提速，有望更早上市，为中国患者提供新的治疗选择。 智通财经APP获悉，同源康医药-B(02410)早盘涨超13%，截至发稿，涨8.94%，报13.52港元，成交额 4070.33万港元。 消息面上，同源康医药公布，公司在研1类新药甲磺酸艾多替尼片(TY-9591片)被国家药品监督管理局 (NMPA)药品审评中心(CDE)纳入优先审评品种名单。 ...

Core Viewpoint - Tongyuan Kang Pharmaceutical-B (02410) experienced a significant stock increase, rising over 13% in early trading and currently up 8.94% at HKD 13.52, with a trading volume of HKD 40.7033 million [1] Group 1: Company Developments - The company announced that its investigational first-class new drug, Tazemetostat (TY-9591), has been included in the priority review list by the National Medical Products Administration (NMPA) [1] - Tazemetostat is intended for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 substitution mutations, along with central nervous system metastases [1] - The inclusion in the priority review list signifies an acceleration in the review process for Tazemetostat, potentially leading to an earlier market launch and providing new treatment options for patients in China [1]

Core Viewpoint - The company Tongyuan Kang Pharmaceutical-B (02410.HK) announced that its investigational first-class new drug, Tyrosine Kinase Inhibitor (TY-9591), has been included in the priority review list by the National Medical Products Administration (NMPA) [1] Group 1 - The application for TY-9591 meets the requirements of the "Drug Registration Management Measures" and the announcement regarding the "Procedures for the Review of Breakthrough Therapy Drugs" [1] - The drug has been accepted into the priority review process under the category of "drugs eligible for conditional approval" [1]

Group 1 - The core point of the article is that the company, 同源康医药-B (02410), has had its investigational drug, Tyrosine Kinase Inhibitor (TY-9591), included in the priority review list by the National Medical Products Administration (NMPA) [1] - The drug is intended for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have EGFR exon 19 deletions (19DEL) or exon 21 (L858R) substitution mutations, along with CNS metastases [1]

Core Viewpoint - The company, ZhiYuanKang Pharmaceutical-B (02410), has announced that its investigational first-class new drug, Tazemetostat (TY-9591), has been included in the priority review list by the National Medical Products Administration (NMPA) [1] Group 1: Drug Information - Tazemetostat (TY-9591) is intended for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have EGFR exon 19 deletions (19DEL) or exon 21 (L858R) substitution mutations, along with CNS metastases [1]

本公司董事會（「董事會」）欣然宣佈，本公司在研1類新藥甲磺酸艾多替尼片 （TY-9591片）被國家藥品監督管理局（「NMPA」）藥品審評中心（「CDE」）納入優 先審評品種名單。現將相關情況公告如下： 藥品的基本情況 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何意見，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 TYK Medicines, Inc 浙江同源康醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2410） 自願公告 甲磺酸艾多替尼片（TY-9591片）被國家藥品 監督管理局藥品審評中心納入優先審評品種名單 浙江同源康醫藥股份有限公司（「本公司」，連同其附屬公司統稱「本集團」）自願刊 發，以告知本公司股東及潛在投資者有關本集團最新業務發展的資料。 | 藥品名稱 | 甲磺酸艾多替尼片（TY-9591片） | | --- | --- | | 劑型與規格 | 片劑，40mg | | 註冊分類 | 化學藥品1類 | | 申請人 | 浙江同源康醫藥股份有限公司 | | 擬定 ...